Allergy drug firm hit by trials setback

Shares in Allergy Therapeutics plunged 22 per cent yesterday after US regulators placed the pharmaceutical company's experimental hayfever vaccine on clinical hold after a report of side-effects.

The Food and Drug Administration is investigating the rare reaction of a patient taking Pollinex Quattro, the company's key product hope, which is in phase three trials in the US.

Allergy said it is co-operating fully with the FDA, and added that having reviewed the data it is unlikely that the side-effects were caused by the drug.

A spokesman added that almost 2,000 people have taken part in two separate phase-three trials in the US for grass allergies and ragweed. One 40-year-old man reported dizzy feelings, numbness and a lack of co-ordination while playing golf, two months after his last injection, and was treated in hospital for three days. He was back in work after two weeks.

"We believe the evidence strongly supports the view that the event was unlikely to have been caused by Pollinex Quattro and we are seeking urgent clarification of the FDA's position," chief executive Keith Carter said.

Allergy had been hoping to launch the vaccine, which is designed to help moderate and severe sufferers of hayfever, in the US by 2009. The timetable could now be delayed due to the setback. Shares in the company fell 26p to 93p yesterday.

Gary Waanders, an analyst at Nomura Code with a buy rating on the stock, questioned why the FDA has taken "what appears to be an extreme position regarding the vaccine's safety". "We believe these symptoms could be related to any number of coincidental conditions," he added. "With this in mind we are very surprised by the hold and expect that the FDA has adopted its position due to recent challenges to its drug safety reviewing process."

The vaccine is already available in Germany, where it has been given to 100,000 hayfever sufferers on a named-patient basis, which is a system that allows doctors to give an unlicensed drug to individuals. The drug, which costs €450 for four shots in Germany, is given in four injections over a three-week period.

source:news.independent.co.uk